MAUDE Adverse Event Report: EQUINOXE; EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Pending revision due to instability.

Manufacturer Narrative

The revision reported was likely the result of either cross-threading or incomplete seating of the reverse torque defining screw allowing it to back out over time, which led to the humeral adapter tray disassociating from the humeral stem and joint instability.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM
• MDR Report Key: 8333075
• MDR Text Key: 135984742
• Report Number: 1038671-2019-00087
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention